Cleared Traditional

K962983 - STERILE SOFT-TEMP

K962983 is an FDA 510(k) clearance for STERILE SOFT-TEMP, manufactured by Adroit Medical Systems, Inc.. The device is a Class 2 Physical Medicine device with product code ILO cleared through the Traditional 510(k) pathway after a 162-day FDA review.

K962983 · Adroit Medical Systems, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1997
Decision
162d
Days
Class 2
Risk

K962983 is an FDA 510(k) clearance for the STERILE SOFT-TEMP. Classified as Pack, Hot Or Cold, Water Circulating (product code ILO), Class II - Special Controls.

Submitted by Adroit Medical Systems, Inc. (Loudon, US). The FDA issued a Cleared decision on January 10, 1997 after a review of 162 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5720 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Adroit Medical Systems, Inc. devices

FDA 510(k) Submission Details - K962983

510(k) Number K962983 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 1996
Decision Date January 10, 1997
Days to Decision 162 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d slower than avg
Panel avg: 115d · This submission: 162d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ILO Device Classification - Class 2, Special Controls

Product Code ILO Pack, Hot Or Cold, Water Circulating
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5720
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.

Regulatory Peers - ILO Pack, Hot Or Cold, Water Circulating

All 35
Devices cleared under the same product code (ILO) and FDA review panel - the closest regulatory comparables to K962983.
ARTROTHERM CRYOTHERAPY AND THERNOTHERAPY
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BLEDSOE COLD CONTROL
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INCARE HOT/ICE SYSTEM BLANKETS (VARIOUS SIZES AND SHAPES)
K964006 · Hollister, Inc. · Dec 1996
INCARE HOT/ICE SYSTEM SHOULDER BLANKET
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POLAR CARE 300
K963596 · Breg, Inc. · Dec 1996